Trial Outcomes & Findings for Positive Activities for Asian American Cancer Patients and Caregivers (NCT NCT05203614)
NCT ID: NCT05203614
Last Updated: 2026-08-13
Results Overview
HRQOL was measured using the 10-item Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) (Cella et al., 2010), with physical and mental health subscales. The scale ranges from 5 to 20 with higher scores indicating better health-related quality of life.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
End-of-study (4 weeks)
Results posted on
2026-08-13
Participant Flow
Data were collected from August 2022 to October 2023, Participants were recruited in person in outpatient clinics or over the phone.
8 participants were excluded from the study before assignment to groups. 3 were excluded due to caregivers not signing informated consent; 5 were excluded due to not completing baseline measures.
Participant milestones
| Measure |
Household Contribution
Participants completed one tangible, useful, or practical activity at home that might contribute to their caregiver's well-being
|
Outside Contribution
Participants completed one tangible, useful, or practical activity each week that would meaningfully contribute to the world outside their home.
|
Control
Participants were asked to report at least 5 of their daily activities from the past 24 hours into a log once a week
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
19
|
14
|
|
Overall Study
Patients
|
10
|
12
|
10
|
|
Overall Study
Caregivers
|
5
|
7
|
4
|
|
Overall Study
COMPLETED
|
14
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
0
|
Reasons for withdrawal
| Measure |
Household Contribution
Participants completed one tangible, useful, or practical activity at home that might contribute to their caregiver's well-being
|
Outside Contribution
Participants completed one tangible, useful, or practical activity each week that would meaningfully contribute to the world outside their home.
|
Control
Participants were asked to report at least 5 of their daily activities from the past 24 hours into a log once a week
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
Baseline Characteristics
Separated by participants and caregivers
Baseline characteristics by cohort
| Measure |
Household Contribution
n=15 Participants
Participants completed one tangible, useful, or practical activity at home that might contribute to their caregiver's well-being
|
Outside Contribution
n=19 Participants
Participants completed one tangible, useful, or practical activity each week that would meaningfully contribute to the world outside their home.
|
Control
n=14 Participants
Participants were asked to report at least 5 of their daily activities from the past 24 hours into a log once a week
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Patients
|
53.0 years
STANDARD_DEVIATION 14.87 • n=10 Participants • Separated by participants and caregivers
|
55.8 years
STANDARD_DEVIATION 12.76 • n=12 Participants • Separated by participants and caregivers
|
55.10 years
STANDARD_DEVIATION 12.26 • n=10 Participants • Separated by participants and caregivers
|
53.65 years
STANDARD_DEVIATION 12.35 • n=32 Participants • Separated by participants and caregivers
|
|
Age, Continuous
Caregivers
|
57.0 years
STANDARD_DEVIATION 11.49 • n=5 Participants • Separated by participants and caregivers
|
48.0 years
STANDARD_DEVIATION 9.47 • n=7 Participants • Separated by participants and caregivers
|
51.00 years
STANDARD_DEVIATION 13.93 • n=4 Participants • Separated by participants and caregivers
|
53.65 years
STANDARD_DEVIATION 12.35 • n=16 Participants • Separated by participants and caregivers
|
|
Sex: Female, Male
Patients · Female
|
4 Participants
n=10 Participants • Separated by participants and caregivers
|
9 Participants
n=12 Participants • Separated by participants and caregivers
|
7 Participants
n=10 Participants • Separated by participants and caregivers
|
20 Participants
n=32 Participants • Separated by participants and caregivers
|
|
Sex: Female, Male
Patients · Male
|
6 Participants
n=10 Participants • Separated by participants and caregivers
|
3 Participants
n=12 Participants • Separated by participants and caregivers
|
3 Participants
n=10 Participants • Separated by participants and caregivers
|
12 Participants
n=32 Participants • Separated by participants and caregivers
|
|
Sex: Female, Male
Caregivers · Female
|
4 Participants
n=5 Participants • Separated by participants and caregivers
|
5 Participants
n=7 Participants • Separated by participants and caregivers
|
2 Participants
n=4 Participants • Separated by participants and caregivers
|
11 Participants
n=16 Participants • Separated by participants and caregivers
|
|
Sex: Female, Male
Caregivers · Male
|
1 Participants
n=5 Participants • Separated by participants and caregivers
|
2 Participants
n=7 Participants • Separated by participants and caregivers
|
2 Participants
n=4 Participants • Separated by participants and caregivers
|
5 Participants
n=16 Participants • Separated by participants and caregivers
|
|
Race (NIH/OMB)
Patients · American Indian or Alaska Native
|
0 Participants
n=10 Participants • Separated by participant and caregiver
|
0 Participants
n=12 Participants • Separated by participant and caregiver
|
0 Participants
n=10 Participants • Separated by participant and caregiver
|
0 Participants
n=32 Participants • Separated by participant and caregiver
|
|
Race (NIH/OMB)
Patients · Asian
|
10 Participants
n=10 Participants • Separated by participant and caregiver
|
11 Participants
n=12 Participants • Separated by participant and caregiver
|
10 Participants
n=10 Participants • Separated by participant and caregiver
|
31 Participants
n=32 Participants • Separated by participant and caregiver
|
|
Race (NIH/OMB)
Patients · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants • Separated by participant and caregiver
|
1 Participants
n=12 Participants • Separated by participant and caregiver
|
0 Participants
n=10 Participants • Separated by participant and caregiver
|
1 Participants
n=32 Participants • Separated by participant and caregiver
|
|
Race (NIH/OMB)
Patients · Black or African American
|
0 Participants
n=10 Participants • Separated by participant and caregiver
|
0 Participants
n=12 Participants • Separated by participant and caregiver
|
0 Participants
n=10 Participants • Separated by participant and caregiver
|
0 Participants
n=32 Participants • Separated by participant and caregiver
|
|
Race (NIH/OMB)
Patients · White
|
0 Participants
n=10 Participants • Separated by participant and caregiver
|
0 Participants
n=12 Participants • Separated by participant and caregiver
|
0 Participants
n=10 Participants • Separated by participant and caregiver
|
0 Participants
n=32 Participants • Separated by participant and caregiver
|
|
Race (NIH/OMB)
Patients · More than one race
|
0 Participants
n=10 Participants • Separated by participant and caregiver
|
0 Participants
n=12 Participants • Separated by participant and caregiver
|
0 Participants
n=10 Participants • Separated by participant and caregiver
|
0 Participants
n=32 Participants • Separated by participant and caregiver
|
|
Race (NIH/OMB)
Patients · Unknown or Not Reported
|
0 Participants
n=10 Participants • Separated by participant and caregiver
|
0 Participants
n=12 Participants • Separated by participant and caregiver
|
0 Participants
n=10 Participants • Separated by participant and caregiver
|
0 Participants
n=32 Participants • Separated by participant and caregiver
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
0 Participants
n=5 Participants • Separated by participant and caregiver
|
0 Participants
n=7 Participants • Separated by participant and caregiver
|
0 Participants
n=4 Participants • Separated by participant and caregiver
|
0 Participants
n=16 Participants • Separated by participant and caregiver
|
|
Race (NIH/OMB)
Caregivers · Asian
|
5 Participants
n=5 Participants • Separated by participant and caregiver
|
7 Participants
n=7 Participants • Separated by participant and caregiver
|
4 Participants
n=4 Participants • Separated by participant and caregiver
|
16 Participants
n=16 Participants • Separated by participant and caregiver
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Separated by participant and caregiver
|
0 Participants
n=7 Participants • Separated by participant and caregiver
|
0 Participants
n=4 Participants • Separated by participant and caregiver
|
0 Participants
n=16 Participants • Separated by participant and caregiver
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
0 Participants
n=5 Participants • Separated by participant and caregiver
|
0 Participants
n=7 Participants • Separated by participant and caregiver
|
0 Participants
n=4 Participants • Separated by participant and caregiver
|
0 Participants
n=16 Participants • Separated by participant and caregiver
|
|
Race (NIH/OMB)
Caregivers · White
|
0 Participants
n=5 Participants • Separated by participant and caregiver
|
0 Participants
n=7 Participants • Separated by participant and caregiver
|
0 Participants
n=4 Participants • Separated by participant and caregiver
|
0 Participants
n=16 Participants • Separated by participant and caregiver
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
0 Participants
n=5 Participants • Separated by participant and caregiver
|
0 Participants
n=7 Participants • Separated by participant and caregiver
|
0 Participants
n=4 Participants • Separated by participant and caregiver
|
0 Participants
n=16 Participants • Separated by participant and caregiver
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=5 Participants • Separated by participant and caregiver
|
0 Participants
n=7 Participants • Separated by participant and caregiver
|
0 Participants
n=4 Participants • Separated by participant and caregiver
|
0 Participants
n=16 Participants • Separated by participant and caregiver
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
19 participants
n=19 Participants
|
14 participants
n=14 Participants
|
48 participants
n=48 Participants
|
PRIMARY outcome
Timeframe: End-of-study (4 weeks)Population: Only complete cases were analyzed (those who completed end-of-study).
Positive and negative affect were measured using a modified 12-item Affect-Adjective Scale (AAS) (Diener \& Emmons, 1984) that included low-arousal emotion items (e.g., peaceful/serene, dull/bored). Participants rated the extent to which they experienced positive and negative emotions over the past week on a scale from 0 ("not at all") to 6 ("extremely").
Outcome measures
| Measure |
Household Contribution
n=14 Participants
Participants completed one tangible, useful, or practical activity at home that might contribute to their caregiver's well-being
|
Outside Contribution
n=13 Participants
Participants completed one tangible, useful, or practical activity each week that would meaningfully contribute to the world outside their home.
|
Control
n=14 Participants
Participants were asked to report at least 5 of their daily activities from the past 24 hours into a log once a week
|
|---|---|---|---|
|
Affect-Adjective Scale
Positive Affect Patients
|
3.44 score on a scale
Standard Deviation 1.14
|
3.57 score on a scale
Standard Deviation 1.04
|
3.83 score on a scale
Standard Deviation 1.23
|
|
Affect-Adjective Scale
Positive Affect Caregivers
|
3.6 score on a scale
Standard Deviation 0.99
|
3.21 score on a scale
Standard Deviation 1.01
|
4.25 score on a scale
Standard Deviation 1.02
|
|
Affect-Adjective Scale
Negative Affect Patients
|
0.96 score on a scale
Standard Deviation 3.14
|
0.87 score on a scale
Standard Deviation 1.06
|
0.77 score on a scale
Standard Deviation 0.7
|
|
Affect-Adjective Scale
Negative Affect Caregivers
|
1.2 score on a scale
Standard Deviation 1.05
|
1.46 score on a scale
Standard Deviation 0.63
|
0.96 score on a scale
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: End-of-study (4 weeks)Population: Only complete cases were analyzed (those who completed end-of-study). Only patients analyzed.
HRQOL was measured using the 10-item Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) (Cella et al., 2010), with physical and mental health subscales. The scale ranges from 5 to 20 with higher scores indicating better health-related quality of life.
Outcome measures
| Measure |
Household Contribution
n=9 Participants
Participants completed one tangible, useful, or practical activity at home that might contribute to their caregiver's well-being
|
Outside Contribution
n=9 Participants
Participants completed one tangible, useful, or practical activity each week that would meaningfully contribute to the world outside their home.
|
Control
n=10 Participants
Participants were asked to report at least 5 of their daily activities from the past 24 hours into a log once a week
|
|---|---|---|---|
|
Health-Related Quality of Life
Physical QOL - Patients
|
13.67 score on a scale
Standard Deviation 2
|
14.67 score on a scale
Standard Deviation 2.87
|
14.3 score on a scale
Standard Deviation 1.57
|
|
Health-Related Quality of Life
Mental QOL - Patients
|
12.56 score on a scale
Standard Deviation 3.17
|
13.22 score on a scale
Standard Deviation 2.33
|
13.5 score on a scale
Standard Deviation 2.07
|
PRIMARY outcome
Timeframe: End-of-study (4 weeks)Population: Only complete cases were analyzed (those who completed end-of-study).
Perceived stress was measured using the 4-item Perceived Stress Scale (PSS) (Cohen \& Willliamson, 1988), which assessed the frequency of stressful experiences over the past month. The scale ranges from 0 to 16 with higher scores indicating greater perceived stress.
Outcome measures
| Measure |
Household Contribution
n=14 Participants
Participants completed one tangible, useful, or practical activity at home that might contribute to their caregiver's well-being
|
Outside Contribution
n=13 Participants
Participants completed one tangible, useful, or practical activity each week that would meaningfully contribute to the world outside their home.
|
Control
n=14 Participants
Participants were asked to report at least 5 of their daily activities from the past 24 hours into a log once a week
|
|---|---|---|---|
|
Perceived Stress
Patients
|
5.11 score on a scale
Standard Deviation 2.21
|
5.56 score on a scale
Standard Deviation 2.56
|
5.1 score on a scale
Standard Deviation 2.73
|
|
Perceived Stress
Caregivers
|
6.8 score on a scale
Standard Deviation 1.92
|
7.5 score on a scale
Standard Deviation 2.08
|
5.25 score on a scale
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: End-of-study (4 weeks)Population: Only complete cases were analyzed (those who completed end-of-study).
Psychological needs were measured with a 9-item version of the Balanced Measure of Psychological Needs (BMPN) (Sheldon \& Hilpert, 2012), which includes subscales for autonomy, competence, and connectedness. The subscales range from 1 to 5 with higher scores indicating greater satisfaction of the respective need.
Outcome measures
| Measure |
Household Contribution
n=14 Participants
Participants completed one tangible, useful, or practical activity at home that might contribute to their caregiver's well-being
|
Outside Contribution
n=13 Participants
Participants completed one tangible, useful, or practical activity each week that would meaningfully contribute to the world outside their home.
|
Control
n=14 Participants
Participants were asked to report at least 5 of their daily activities from the past 24 hours into a log once a week
|
|---|---|---|---|
|
Psychological Needs
Competence - Patients
|
3.82 score on a scale
Standard Deviation 0.78
|
3.81 score on a scale
Standard Deviation 1.13
|
4 score on a scale
Standard Deviation 0.85
|
|
Psychological Needs
Autonomy - Patients
|
4.07 score on a scale
Standard Deviation 0.7
|
4.11 score on a scale
Standard Deviation 0.78
|
4.1 score on a scale
Standard Deviation 0.74
|
|
Psychological Needs
Autonomy - Caregivers
|
3.73 score on a scale
Standard Deviation 0.6
|
3.92 score on a scale
Standard Deviation 1.1
|
4.33 score on a scale
Standard Deviation 0.47
|
|
Psychological Needs
Competence - Caregivers
|
3.73 score on a scale
Standard Deviation 0.55
|
3.67 score on a scale
Standard Deviation 1.41
|
4 score on a scale
Standard Deviation 0.72
|
|
Psychological Needs
Connectedness - Patients
|
3.93 score on a scale
Standard Deviation 0.6
|
3.96 score on a scale
Standard Deviation 0.86
|
4.27 score on a scale
Standard Deviation 0.63
|
|
Psychological Needs
Connectedness - Caregivers
|
3.87 score on a scale
Standard Deviation 0.3
|
3.58 score on a scale
Standard Deviation 1.45
|
4.5 score on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: End-of-study (4 weeks)Population: Only patients analyzed.
Self-perceived burden was measured using the 10-item Self-Perceived Burden Scale (SPBS) (Cousineau et al., 2003), which assessed the extent to which patients felt that they were a burden on caregivers. The scale ranges from 10 to 50 with higher scores indicating greater self=perceived burden.
Outcome measures
| Measure |
Household Contribution
n=9 Participants
Participants completed one tangible, useful, or practical activity at home that might contribute to their caregiver's well-being
|
Outside Contribution
n=9 Participants
Participants completed one tangible, useful, or practical activity each week that would meaningfully contribute to the world outside their home.
|
Control
n=10 Participants
Participants were asked to report at least 5 of their daily activities from the past 24 hours into a log once a week
|
|---|---|---|---|
|
Self-Perceived Burden
|
20.44 score on a scale
Standard Deviation 9.89
|
17.33 score on a scale
Standard Deviation 4.58
|
19.3 score on a scale
Standard Deviation 4.74
|
Adverse Events
Household Contribution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Outside Contribution
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Household Contribution
n=15 participants at risk
Participants completed one tangible, useful, or practical activity at home that might contribute to their caregiver's well-being
|
Outside Contribution
n=19 participants at risk
Participants completed one tangible, useful, or practical activity each week that would meaningfully contribute to the world outside their home.
|
Control
n=14 participants at risk
Participants were asked to report at least 5 of their daily activities from the past 24 hours into a log once a week
|
|---|---|---|---|
|
General disorders
Patient did not feel well enough to do study activities
|
0.00%
0/15 • baseline to study completion, an average of 5 weeks
|
5.3%
1/19 • baseline to study completion, an average of 5 weeks
|
0.00%
0/14 • baseline to study completion, an average of 5 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place